Prosthetic Heart Valves With Tether Coupling Features

ABSTRACT

Apparatus and methods are described herein for various embodiments of a prosthetic heart valve that have a tether securement feature that can be used to secure an anchoring tether to the prosthetic heart valve such that the tether can maintain the prosthetic heart valve in a desired position within the heart under high tensile forces applied to the tether during functioning of the heart. In some embodiments the tether securement feature can also include an engagement member that can be used to help position the prosthetic heart valve within a heart. Such an engagement member can be matingly engaged by a positioning device that can be used to help in radial positioning of the prosthetic heart valve during delivery and deployment of the prosthetic heart valve.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62/550,967, entitled “Prosthetic Heart Valves with Tether Coupling Features,” filed Aug. 28, 2017, the disclosure of which is incorporated herein by reference in its entirety.

BACKGROUND

Embodiments are described herein that relate to devices and methods for use in the delivery and deployment of prosthetic heart valves, and particularly to devices and methods for prosthetic heart valves having a tether securement portion to secure an anchoring tether to the prosthetic heart valve.

Prosthetic heart valves can pose particular challenges for delivery and deployment within a heart. Valvular heart disease, and specifically, aortic and mitral valve disease is a significant health issue in the United States (US); annually approximately 90,000 valve replacements are conducted in the US. Traditional valve replacement surgery involving the orthotopic replacement of a heart valve is considered an “open heart” surgical procedure. Briefly, the procedure necessitates surgical opening of the thorax, the initiation of extra-corporeal circulation with a heart-lung machine, stopping and opening the heart, excision and replacement of the diseased valve, and re-starting of the heart. While valve replacement surgery typically carries a 1-4% mortality risk in otherwise healthy persons, a significantly higher morbidity is associated to the procedure largely due to the necessity for extra-corporeal circulation. Further, open heart surgery is often poorly tolerated in elderly patients. Thus elimination of the extra-corporeal component of the procedure could result in reduction in morbidities and cost of valve replacement therapies could be significantly reduced.

While replacement of the aortic valve in a transcatheter manner is the subject of intense investigation, lesser attention has been focused on the mitral valve. This is in part reflective of the greater level of complexity associated to the native mitral valve apparatus, and thus, a greater level of difficulty with regards to inserting and anchoring the replacement prosthesis. A need exists for delivery devices and methods for transcatheter mitral valve replacements.

Some known delivery methods include delivering a prosthetic mitral valve through an apical puncture site. In such a procedure, the valve is placed in a compressed configuration within a lumen of a delivery catheter of, for example, 34-36 Fr (i.e. an outer diameter of about 11-12 mm). Delivery of a prosthetic valve to the atrium of the heart can be accomplished, for example, via a transfemoral approach, transatrially directly into the left atrium of the heart or via a jugular approach. After the prosthetic heart valve has been deployed, various known anchoring techniques have been used. For example, some prosthetic heart valves are anchored within the heart using anchoring mechanisms attached to the valve, such as barbs, or other features that can engage surrounding tissue in the heart and maintain the prosthetic valve in a desired position within the heart. Some known anchoring techniques include the use of an anchoring tether that is attached to the valve and anchored to a location on the heart such as an interior or exterior wall of the heart.

A need exists for improved techniques for securing an anchoring tether to a prosthetic heart valve that can provide for a secure attachment of the anchoring tether to the valve and also provide for maintaining the prosthetic heart valve in a desired position in the heart during normal heart functioning. A need also exists for devices and methods for aiding in the delivery and positioning of a prosthetic heart valve within a heart

SUMMARY

Apparatus and methods are described herein for various embodiments of a prosthetic heart valve that have a tether securement feature that can be used to secure an anchoring tether to the prosthetic heart valve such that the tether can maintain the prosthetic heart valve in a desired position within the heart under high tensile forces applied to the tether during functioning of the heart. In some embodiments the tether securement feature can also include an engagement member that can be used to help position the prosthetic heart valve within a heart. Such an engagement member can be matingly engaged by a positioning device that can be used to help in radial positioning of the prosthetic heart valve during delivery and deployment of the prosthetic heart valve.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a schematic illustration of a prosthetic heart valve, according to an embodiment.

FIGS. 2A and 2B are each a schematic illustration of a portion of the prosthetic heart valve of FIG. 1 and a positioning device.

FIGS. 3-5 are front, bottom, and top views of a prosthetic heart valve according to an embodiment.

FIG. 6 is an opened and flattened view of the inner frame of the prosthetic heart valve of FIGS. 3-5, in an unexpanded configuration.

FIGS. 7 and 8 are side and bottom views, respectively, of the inner frame of FIG. 6 in an expanded configuration.

FIG. 9 is an opened and flattened view of the outer frame of the valve of FIGS. 3-5, in an unexpanded configuration.

FIGS. 10 and 11 are side and top views, respectively, of the outer frame of FIG. 9 in an expanded configuration.

FIGS. 12-14 are side, front, and top views of an assembly of the inner frame of FIGS. 6-8 and the outer frame of FIGS. 9-11.

FIG. 15 is a side perspective view of an assembly of an inner frame and an outer frame shown in a biased expanded configuration, according to an embodiment.

FIG. 16 is a side perspective view of the assembly of FIG. 15 with the outer frame shown inverted.

FIG. 17 is a side view of the assembly of FIG. 16 shown in a collapsed configuration within a lumen of a delivery sheath.

FIG. 18 is a side view of the assembly of FIG. 17 shown in a first partially deployed configuration.

FIG. 19 is a side view of the assembly of FIG. 17 shown in a second partially deployed configuration.

FIG. 20 is a side view of the assembly of FIG. 17 shown in a third partially deployed configuration in which the inverted outer frame is substantially deployed outside of the delivery sheath.

FIG. 21 is a side view of the assembly of FIG. 17 shown in a fourth partially deployed configuration in which the outer frame has reverted and assumed a biased expanded configuration.

FIGS. 22-24 illustrate steps of a portion of a method to deliver the prosthetic valve of FIGS. 15-21 to an atrium of a heart and within the native mitral annulus.

FIG. 25A is a side view of a portion of an inner frame of a prosthetic heart valve, according to another embodiment.

FIG. 25B is an enlarged view of a strut in the tether connecting portion of the prosthetic valve of FIG. 25A.

FIG. 26 is an opened and flattened view of the inner frame of the prosthetic heart valve of FIG. 25A, in an unexpanded configuration.

FIG. 27 is a side view of a portion of the inner frame of the prosthetic heart valve of FIG. 25A shown coupled to a tether.

FIG. 28 is an enlarged view of a portion of the inner frame and tether of FIG. 27 illustrating the coupling of the inner frame to the tether with sutures.

FIG. 29 is an enlarged view of a portion of the inner frame and tether of FIG. 28 illustrating the coupling of the inner frame to the tether with sutures.

FIG. 30 is a side view of a portion of an inner frame of a prosthetic heart valve having a positive engagement feature at the tether connecting portion, according to an embodiment.

FIG. 31 is an opened and flattened view of the inner frame of the prosthetic heart valve of FIG. 30, in an unexpanded configuration.

FIG. 32 is an enlarged view of a portion of the inner frame and tether of FIG. 30 illustrating the coupling of the inner frame to the tether with sutures.

FIG. 33 is an enlarged view of a portion of the inner frame and tether of FIG. 32 illustrating the coupling of the inner frame to the tether with sutures.

DETAILED DESCRIPTION

Apparatus and methods are described herein for prosthetic heart valves, such as prosthetic mitral valves, that can include a tether securement or coupling portion that can be used to secure an anchoring tether to the prosthetic heart valve. As described herein, in some embodiments, a prosthetic heart valve includes an outer frame and an inner frame coupled to the outer frame. The inner frame can include a tether coupling portion disposed at a proximal end portion of the prosthetic heart valve. The prosthetic heart valve can be formed with, for example, a shape-memory material and the anchoring tether can be, for example, formed with a braided filament. In some embodiments, the anchoring tether can be coupled to the tether coupling portion of the valve with a compressive force. In some embodiments, one or more sutures can be used to secure the tether coupling portion to the anchoring tether. In some embodiments, the tether coupling portion can include an engagement feature that can be matingly and releasably engaged by an engagement portion of a positioning device that can be used to help position the prosthetic heart valve in a desired location within the heart.

In some embodiments, a prosthetic heart valve includes an outer frame and an inner frame coupled to the outer frame. The inner frame includes a tether coupling portion disposed at a proximal end portion of the prosthetic heart valve. An anchoring tether is coupled to the tether coupling portion of the inner frame with at least one suture. The anchoring tether is configured to be secured to a wall of a heart of a patient to secure a position of the prosthetic heart valve within the heart of the patient.

In some embodiments, a kit includes a prosthetic heart valve and a positioning device. The prosthetic valve includes an outer frame, an inner frame coupled to the outer frame, and an anchoring tether coupled to the inner frame. The inner frame includes a tether coupling portion disposed at a proximal end portion of the prosthetic heart valve. The anchoring tether is coupled to the tether coupling portion of the inner frame with at least one suture and is configured to be secured to a wall of a heart of a patient to secure a position of the prosthetic heart valve within the heart of the patient. The positioning device is configured to engage the tether coupling portion of the inner frame and to be used to help position the prosthetic heart valve within the heart of the patient.

A prosthetic heart valve can be delivered to a heart of patient using a variety of different delivery approaches for delivering a prosthetic heart valve (e.g., prosthetic mitral valve). For example, the prosthetic heart valves described herein can be delivered using a transfemoral delivery approach as described in PCT International Application No. PCT/US15/14572 (referred to herein as the '572 PCT Application) and International Application No. PCT International Application No. PCT/US2016/012305 (referred to herein as “the '305 PCT Application”) each of the disclosures of which is incorporated by reference herein in its entirety, or via a transatrial approach or a transjugular approach such as described in U.S. Patent Application Pub. No. 2017/0079790 (the '290 publication), the disclosure of which is incorporated herein by reference in its entirety. The prosthetic valves described herein can also be delivered apically if desired.

In one example, where the prosthetic heart valve is a prosthetic mitral valve, the valve is placed within a lumen of a delivery sheath in a collapsed configuration. A distal end portion of a delivery sheath can be disposed within the left atrium of the heart, and the prosthetic valve can be moved out of the lumen of the delivery sheath and allowed to move to a biased expanded configuration. The prosthetic mitral valve can then be positioned within a mitral annulus of the heart. As described herein, in some embodiments, the tether coupling portion of the valve can include an engagement portion that can be matingly engaged by a positioning device. The positioning device can be inserted through an opening in the apex portion of the heart and moved into engagement with the engagement portion of the valve. The positioning device can then be used to help position the valve within, for example, the mitral annulus of the heart.

FIG. 1 is a schematic illustration of a prosthetic heart valve 100, according to an embodiment, and FIGS. 2A and 2B are schematic illustrations of a tether coupling portion of the prosthetic heart valve and a positioning device 190, according to an embodiment. The prosthetic heart valve 100 (also referred to herein as “prosthetic valve” or “valve”) can be, for example, a prosthetic mitral valve. The valve 100 can be delivered and deployed within an atrium of a heart using a variety of different delivery approaches including, for example, a transfemoral delivery approach, as described in the '572 PCT application and the '305 PCT application, or a transatrial approach or transjugular approach, as described in the '290 publication. The positioning device 190 can be used to help position the valve 100 within the atrium of the heart. For example, the positioning device 190 can be inserted into the heart via an apical access opening and a distal end portion of the positioning device 190 can engage with and be releasably coupled to the valve 100 such that the positioning device 190 can be used to provide better control and maneuvering of the valve 100. In some embodiments, the prosthetic valve 100 and the positioning device 190 can be provided together in a kit. In some embodiments, such a kit can have other devices such as a valve delivery device.

The valve 100 includes an outer frame assembly having an outer frame 120 and an inner valve assembly having an inner frame 150. Each of the outer frame 120 and the inner frame 150 can be formed as a tubular structure as described in more detail below with reference to FIGS. 3-14. The outer frame 120 and the inner frame 150 can be coupled together at multiple coupling joints (not shown) disposed about a perimeter of the inner frame 150 and a perimeter of the outer frame 120. The valve 100 can also include other features, such as those described with respect to FIGS. 3-14 below. For illustration purposes, only the inner frame 150 and the outer frame 120 are discussed with respect to FIGS. 1 and 2. The various characteristics and features of valve 100 described with respect to FIGS. 1 and 2 can apply to any of the prosthetic valves described here.

The outer frame 120 is configured to have a biased expanded or undeformed shape and can be manipulated and/or deformed (e.g., compressed or constrained) and, when released, return to its original (expanded or undeformed) shape. For example, the outer frame can be formed of materials, such as metals or plastics, which have shape memory properties. With regards to metals, Nitinol® has been found to be especially useful since it can be processed to be austenitic, martensitic or super elastic. Other shape memory alloys, such as Cu—Zn—Al—Ni alloys, and Cu—Al—Ni alloys, may also be used. The inner frame can be formed from a laser-cut tube of Nitinol®. The inner frame 150 can also have a biased expanded or undeformed shape and can be manipulated and/or deformed (e.g., compressed and/or constrained) and, when released, return to its original (expanded or undeformed) shape. Further details regarding the inner frame and the outer frame are described below with respect to valve 200 and FIGS. 3-14.

As shown in more detail with respect to inner frame 250 (see, e.g., FIGS. 6-8), the inner frame 150 can be formed from a laser-cut tube of Nitinol®. Inner frame 150 can be divided into four portions, corresponding to functionally different portions of the inner frame 150 in final form: atrial portion 147, body portion 142, strut portion 143, and tether clamp or connecting portion 144. In the schematic illustration of FIG. 1, the atrial and body portions (147 and 142) are within the outer frame 120, indicated by the dashed lines.

The strut portion 143 of the inner frame 150 can include a suitable number of individual struts which connect the body portion 142 to the tether connecting portion 144. For example, FIG. 6 shows an inner frame 250 of an embodiment similar to inner frame 150 of FIG. 1. The inner frame 150 can be formed the same or similar way and include the same or similar portions and/or functions as inner frame 250 shown in FIG. 6.

The strut portion 143 of inner frame 150 can include struts (not shown in FIGS. 1, 2A and 2B) (e.g., see struts 243 a in FIG. 6) that connect the body portion 142 with the tether connecting portion 144. In some embodiments, the tether connecting portion 144 can include longitudinal extensions of the struts of the strut portion 143 that can be connected circumferentially by pairs of opposed, slightly V-shaped connecting members (or “micro-Vs”) (see, e.g., inner frame 250 in FIG. 6). For example, in some embodiments, the strut portion 143 can include six struts that extend to form six struts of the tether connecting portion 144, with each of the six struts of the tether connecting portion 144 connected circumferentially by micro-Vs.

The tether connecting portion or the coupling portion 144 (also referred to as first end portion of inner frame 150) can be configured to be radially collapsible by application of a compressive force as described in more detail below with reference to valve 200 and inner frame 250. Thus, tether connecting portion 144 can be configured to compressively clamp or grip one end of a tether 136 (e.g. braided filament line), either connecting directly onto the tether 136 or onto an intermediate structure, such as a polymer or metal piece that is in turn firmly fixed to the tether 136 (not shown). The tether connecting portion 144 can also include openings (not shown in FIGS. 1, 2A and 2B) through which sutures or wires can be inserted to fasten around the collapsed struts and around the end of the tether 136 to couple the tether 136 to the tether connecting portion 144.

As described above, in some embodiments, the strut portion 143 can include, for example, six struts each extending to form six struts of the tether connecting portion 144. In other embodiments, the strut portion 143 can include a different number of struts and/or can include a different configuration and formation of struts as described in more detail below.

For example, in some embodiments, the valve 100 can include a strut portion 143 that includes six struts, with every two struts of the six struts coming together or being fused into a single strut of the tether connecting portion 144. In other words, the strut portion 143 includes three pairs of struts and the tether connecting portion 144 includes three struts. Each of the three struts of the tether connecting portion 144 can define openings for insertion of sutures for fastening the tether 136 to the tether connecting portion 144. The combining of a pair of struts from the strut portion 143 to form a single strut of the tether connecting portion 144 can provide increased wall thickness at the end portion of the tether connecting portion 144, providing a robust tether connecting portion 144 with high tensile capacity to hold the tether 136 when sutured in.

In some embodiments six struts may be combined to form three pairs of combined or fused tether struts with openings provided for sutures and/or wires. In other embodiments, only a subset of pairs of struts may come together while others remain singly extended to the tether connecting portion 144. For example, one or two pairs may come together while the remaining two or more struts are singly extending to the tether connecting portion.

Additionally, the pairs of struts that are joined to form the strut of the tether connecting portion may either be pre-formed in the joined or fused state or formed as separate struts and coupled together with a suitable fastening mechanism to form a single tether connecting portion strut. The struts of the strut portion can be, for example, releasably or fixedly coupled together to form the combined strut of the tether connecting portion. The struts of the strut portion may also be configured to be separate until sutured together at the time of being coupled to the tether 136.

The tether connecting portion 144 can also include an engagement feature 122 that can be matingly engaged with or releasably coupled to a corresponding engagement feature 123 on the positioning device 190 as shown in FIGS. 2A and 2B. FIGS. 2A and 2B show the engagement features 122 and 123 disengaged and engaged, respectively. The engagement features 122 and 123 can be used to releasably couple the valve 100 to the positioning device 190 such that the positioning device 190 can be used to help in the positioning of the valve 100 within a heart during deployment of the valve 100. For example, the positioning device 190 can define a lumen through which the tether 136 can be received therethrough, and the positioning device 190 can be inserted through the apex of the heart and moved distally to engagement with the valve 100 via the engagement features 122, 123. Upon engagement, the transapical positioning device 190 can be used to radially position the valve 100 within the heart by applying torque to turn the valve 100 about the axis of the tether 136.

The illustrations in FIGS. 2A and 2B show the engagement feature 122 on the tether connecting portion 144 to be an extension or protrusion and the counter engagement feature 123 on the positioning device 190 (e.g., a transapical positioning device) to be an aperture or slot to matingly connect with the engagement feature 122. For example, the engagement feature 122 can be configured as an extension of one or more of the struts of the tether connecting portion 144. Such an embodiment is described below with respect to valve 400. In other embodiments, the engagement feature 122 can be a slot or aperture while the counter engagement feature 123 on the positioning device 190 is an extension to be received within the slot or aperture. Alternatively, other types of suitable configurations can be used to enable releasably attaching the positioning device 190 to the tether connecting portion 144 to facilitate radial positioning by applying torque about the axis of the tether 136. Although a single engagement feature 122 and a single engagement feature 123 are shown in FIGS. 2A and 2B, in other embodiments, the tether connecting portion 144 can include more than one engagement feature 122 and the positioning device 190 can include a corresponding number of engagement features 123 to matingly couple thereto.

FIGS. 3-14 illustrate another embodiment of a prosthetic heart valve that can be delivered and deployed within a left atrium of a heart using a variety of different delivery approaches including, for example, a transfemoral delivery approach or a transatrial delivery approach. FIGS. 3-5 are front, bottom, and top views, respectively, of a prosthetic heart valve 200 according to an embodiment. Prosthetic heart valve 200 (also referred to herein as “valve” or “prosthetic valve”) is designed to replace a damaged or diseased native heart valve such as a mitral valve. Valve 200 includes an outer frame assembly 210 and an inner valve assembly 240 coupled to the outer frame assembly 210.

As shown, outer frame assembly 210 includes an outer frame 220, covered on all or a portion of its outer face with an outer covering 230, and covered on all or a portion of its inner face by an inner covering 232. Outer frame 220 can provide several functions for prosthetic heart valve 200, including serving as the primary structure, as an anchoring mechanism and/or an attachment point for a separate anchoring mechanism to anchor the valve to the native heart valve apparatus, a support to carry inner valve assembly 240, and/or a seal to inhibit paravalvular leakage between prosthetic heart valve 200 and the native heart valve apparatus.

Outer frame 220 has a biased expanded configuration and can be manipulated and/or deformed (e.g., compressed and/or constrained) and, when released, return to its original unconstrained shape. To achieve this, outer frame 220 can be formed of materials, such as metals or plastics that have shape memory properties. With regards to metals, Nitinol® has been found to be especially useful since it can be processed to be austenitic, martensitic or super elastic. Other shape memory alloys, such as Cu—Zn—Al—Ni alloys, and Cu—Al—Ni alloys, may also be used.

As best shown in FIG. 3, outer frame assembly 210 has an upper end (e.g., at the atrium portion 216), a lower end (e.g., at the ventricle portion 212), and a medial portion (e.g., at the annulus portion 214) therebetween. The upper end or atrium portion 216 (also referred to as “outer free end portion”) defines an open end portion of the outer frame assembly 210. The medial or annulus portion 214 of the outer frame assembly 210 has a perimeter that is configured (e.g., sized, shaped) to fit into an annulus of a native atrioventricular valve. The upper end of the outer frame assembly 210 has a perimeter that is larger than the perimeter of the medial portion. In some embodiments, the perimeter of the upper end of the outer frame assembly 210 has a perimeter that is substantially larger than the perimeter of the medial portion. As shown best in FIG. 5, the upper end and the medial portion of the outer frame assembly 210 has a D-shaped cross-section. In this manner, the outer frame assembly 210 promotes a suitable fit into the annulus of the native atrioventricular valve.

Inner valve assembly 240 includes an inner frame 250, an outer covering (not shown), and leaflets 270. As shown, the inner valve assembly 240 includes an upper portion having a periphery formed with multiple arches. The inner frame 250 includes six axial posts or frame members that support the outer covering of the inner valve assembly and leaflets 270. Leaflets 270 are attached along three of the posts, shown as commissure posts 252 (best illustrated in FIG. 4), and the outer covering of the inner valve assembly 240 is attached to the other three posts, 254 (best illustrated in FIG. 4), and optionally to commissure posts 252. Each of the outer covering of the inner valve assembly 240 and leaflets 270 are formed of approximately rectangular sheets of material, which are joined together at their upper, or atrium end. The lower, ventricle end of the outer covering may be joined to inner covering 232 of outer frame assembly 210, and the lower, ventricle end of leaflets 270 may form free edges 275, though coupled to the lower ends of commissure posts 252.

Although inner valve assembly 240 is shown as having three leaflets, in other embodiments, an inner valve assembly can include any suitable number of leaflets. The leaflets 270 are movable between an open configuration and a closed configuration in which the leaflets 270 coapt, or meet in a sealing abutment.

Outer covering 230 of the outer frame assembly 210 and inner covering 232 of outer frame assembly 210, and the outer covering of the inner valve assembly 240 and leaflets 270 of the inner valve assembly 240 may be formed of any suitable material, or combination of materials, such as those discussed above. In this embodiment, the inner covering 232 of the outer frame assembly 210, the outer covering of the inner valve assembly 240, and the leaflets 270 of the inner valve assembly 240 are formed, at least in part, of porcine pericardium. Moreover, in this embodiment, the outer covering 230 of the outer frame assembly 210 is formed, at least in part, of polyester.

Inner frame 250 is shown in more detail in FIGS. 6-8. Specifically, FIGS. 6-8 show inner frame 250 in an undeformed, initial state (FIG. 6), a side view of the inner frame 250 in an expanded configuration (FIG. 7), and a bottom view of the inner frame 250 in the expanded configuration (FIG. 8), respectively, according to an embodiment.

In this embodiment, inner frame 250 is formed from a laser-cut tube of Nitinol®. Inner frame 250 is illustrated in FIG. 6 in an undeformed, initial state, i.e. as laser-cut, but cut and unrolled into a flat sheet for ease of illustration. Inner frame 250 can be divided into four portions, corresponding to functionally different portions of the inner frame 250 in final form: atrial portion 247, body portion 242, strut portion 243, and tether clamp or connecting portion 244. Strut portion 243 includes six struts, such as strut 243A, which connect body portion 242 to tether connecting portion 244.

Tether connecting portion 244 (also referred to as first end portion of inner frame) includes longitudinal extensions of the struts, connected circumferentially by pairs of opposed, slightly V-shaped connecting members (or “micro-Vs”). Tether connecting portion 244 is configured to be radially collapsed by application of a compressive force, which causes the micro-Vs to become more deeply V-shaped, with the vertices moving closer together longitudinally and the open ends of the V shapes moving closer together circumferentially. Thus, tether connecting portion 244 can be configured to compressively clamp or grip one end of a tether, either connecting directly onto a tether line (e.g. braided filament line) or onto an intermediate structure, such as a polymer or metal piece that is in turn firmly fixed to the tether line.

In contrast to tether connecting portion 244, atrial portion 247 (also referred to as “inner frame free end portion”) and body portion 242 are configured to be expanded radially. Strut portion 243 forms a longitudinal connection and radial transition between the expanded body portion and the compressed tether connecting portion 244. Body portion 242 provides an inner frame coupling portion 245 that includes six longitudinal posts, such as post 242A. The inner frame coupling portion 245 can be used to attach leaflets 270 to inner frame 240, and/or can be used to attach inner assembly 240 to outer assembly 210, such as by connecting inner frame 250 to outer frame 220. In the illustrated embodiment, the posts include openings through which connecting members (such as suture filaments and/or wires) can be passed to couple the posts to other structures.

Inner frame 250 is shown in a fully deformed, i.e. the final, deployed configuration, in side view and bottom view in FIGS. 7 and 8, respectively.

Outer frame 220 of valve 200 is shown in more detail in FIGS. 9-11. In this embodiment, outer frame 220 is also formed from a laser-cut tube of Nitinol®. Outer frame 220 is illustrated in FIG. 9 in an undeformed, initial state, i.e. as laser-cut, but cut and unrolled into a flat sheet for ease of illustration. Outer frame 220 can be divided into an outer frame coupling portion 271, a body portion 272, and a cuff portion 273 (which includes the atrium or free end portion 216), as shown in FIG. 9. Outer frame coupling portion 271 includes multiple openings or apertures, such as 271A, by which outer frame 220 can be coupled to inner frame 250, as discussed in more detail below.

Outer frame 220 is shown in a fully deformed, i.e. the final, deployed configuration, in side view and top view in FIGS. 10 and 11, respectively. As best seen in FIG. 11, the lower end of outer frame coupling portion 271 forms a roughly circular opening (identified by “O” in FIG. 11). The diameter of this opening preferably corresponds approximately to the diameter of body portion 242 of inner frame 250, to facilitate coupling of the two components of valve 200.

Outer frame 220 and inner frame 250 are shown coupled together in FIGS. 12-14, in front, side, and top views, respectively. The two frames collectively form a structural support for a prosthetic valve such as valve 200. The frames support the valve leaflet structure (e.g., leaflets 270) in the desired relationship to the native valve annulus, support the coverings (e.g., outer covering 230 and inner covering 232 of outer frame assembly 210, outer covering of inner valve assembly 240) for the two frames to provide a barrier to blood leakage between the atrium and ventricle, and couple to a tether (not shown in FIGS. 3-14) (e.g., tether 136 described above with respect to FIGS. 1, 2A and 2B) by the inner frame 250 to aid in holding the prosthetic valve 200 in place in the native valve annulus by the tether connection to the ventricle wall. The outer frame 220 and the inner frame 250 are connected at six coupling points (representative points are identified as “C” in FIGS. 12-14). In this embodiment, the coupling points are implemented with a mechanical fastener, such as a short length of wire, passed through an aperture (such as aperture 271A) in outer frame coupling portion 271 and corresponding openings in inner frame coupling portion 245 (e.g., longitudinal posts, such as post 242A) in body portion 242 of inner frame 250. Inner frame 250 is thus disposed within the outer frame 220 and securely coupled to it.

FIGS. 15-21 illustrate a method of reconfiguring a prosthetic heart valve 300 (e.g., prosthetic mitral valve) prior to inserting the prosthetic heart valve 300 into a delivery sheath 326 (see, e.g., FIGS. 17-21) for delivery into the atrium of the heart. The prosthetic heart valve 300 (also referred to herein as “valve”) can be constructed the same as or similar to, and function the same as or similar to the valves 100 and 200 described above. Thus, some details regarding the valve 300 are not described below. It should be understood that for features and functions not specifically discussed, those features and functions can be the same as or similar to the valve 200.

As shown in FIG. 15, the valve 300 has an outer frame 320 and an inner frame 350. As discussed above for valves 100 and 200, the outer frame 320 and the inner frame 350 of valve 300 can each be formed with a shape-memory material and have a biased expanded configuration. The outer frame 320 and the inner frame 350 can be moved to a collapsed configuration for delivery of the valve 300 to the heart. In this example method of preparing the valve 300 for delivery to the heart, the outer frame 320 of the valve 300 is first disposed in a prolapsed or inverted configuration as shown in FIG. 16. Specifically, the elastic or superelastic structure of outer frame 320 of valve 300 allows the outer frame 320 to be disposed in the prolapsed or inverted configuration prior to the valve 300 being inserted into the lumen of the delivery sheath 326. As shown in FIG. 16, to dispose the outer frame 320 in the inverted configuration, the outer frame 320 is folded or inverted distally (to the right in FIG. 16) such that an open free end 316 of the outer frame 320 is pointed away from an open free end 347 of the inner frame 350. As described above for valve 100, in this inverted configuration, the overall outer perimeter or outer diameter of the valve 300 is reduced and the overall length is increased. For example, the diameter D1 shown in FIG. 15 is greater than the diameter D2 shown in FIG. 16, and the length L1 (shown in FIG. 12 for valve 200) is less than the length L2 shown in FIG. 16 for valve 300. With the outer frame 320 in the inverted configuration relative to the inner frame 350, the valve 300 can be placed within a lumen of a delivery sheath 326 as shown in FIG. 17 for delivery of the valve 300 to the left atrium of the heart. By disposing the outer frame 320 in the inverted configuration relative to the inner frame 350, the valve 300 can be collapsed into a smaller overall diameter, i.e. when placed in a smaller diameter delivery sheath, than would be possible if the valve 300 in the configuration shown in FIG. 15 were collapsed radially without being inverted. This is because in the configuration shown in FIG. 15, the two frames are concentric or nested, and thus the outer frame 320 must be collapsed around the inner frame 350, whereas in the configuration shown in FIG. 16, the two frames are substantially coaxial but not concentric or nested. Thus, in the configuration shown in FIG. 16 the outer frame 320 can be collapsed without the need to accommodate the inner frame 350 inside of it. In other words, with the inner frame 350 disposed mostly inside or nested within the outer frame 320, the layers or bulk of the frame structures cannot be compressed to as small a diameter. In addition, if the frames are nested, the structure is less flexible, and therefore, more force is needed to bend the valve, e.g. to pass through tortuous vasculature or to make a tight turn in the left atrium after passing through the atrial septum to be properly oriented for insertion into the mitral valve annulus.

FIGS. 22-24 illustrate a portion of a procedure to deliver the valve 300 to the heart. In this embodiment, the valve 300 is shown being delivered via a transfemoral delivery approach as described, for example, in the '305 PCT application incorporated by reference above. The delivery sheath 326, with the valve 300 disposed within a lumen of the delivery sheath 326 and in an inverted configuration as shown in FIG. 17, can be inserted into a femoral puncture, through the femoral vein, through the inferior vena cava, into the right atrium, through the septum Sp and into the left atrium LA of the heart. With the distal end portion of the delivery sheath 326 disposed within the left atrium of the heart, the valve 300 can be deployed outside a distal end of the delivery sheath 326. For example, in some embodiments, a pusher device 338 can be used to move or push the valve 300 out the distal end of the delivery sheath 326. As shown in FIGS. 22-24, a tether 336 can be attached to the valve 300, and extend through the mitral annulus, through the left ventricle LV, and out a puncture site at the apex Ap. In some embodiments, the valve 300 can be moved out of the delivery sheath 326 by pulling proximally on the tether 336. In some embodiments, the valve 300 can be deployed by pushing with the pusher device and pulling with the tether.

As the valve 300 exits the lumen of the delivery sheath 326, the outer frame assembly 310 exits first in its inverted configuration as shown in the progression of FIGS. 18-20 (see also FIG. 22). After the outer frame assembly 310 is fully outside of the lumen of the delivery sheath 326, the outer frame 320 can revert to its expanded or deployed configuration as shown in FIGS. 21, 23 and 24. In some embodiments, the outer frame 320 can revert automatically after fully exiting the lumen of the delivery sheath due to its shape-memory properties. In some embodiments, a component of the delivery sheath or another device can be used to aid in the reversion of the outer frame assembly 310. In some embodiments, the pusher device and/or the tether can be used to aid in the reversion of the outer frame assembly 310. The valve 300 can continue to be deployed until the inner frame 350 is fully deployed with the left atrium and the valve 300 is in the expanded or deployed configuration (as shown, e.g., in FIGS. 15 and 24). The valve 300 and the tether 336 can then be secured to the apex of the heart with an epicardial pad device 339 as shown in FIG. 24 and as described in more detail in the '572 PCT application and the '305 PCT application.

FIG. 25A illustrates another embodiment of a prosthetic heart valve 400. The valve 400 can be substantially similar to other prosthetic heart valves described above. For example, the valve 400 can be constructed the same as or similar to, and function the same as or similar to the valves 100 and 200 described above. The valve 400 includes an outer frame assembly (not shown) and an inner valve assembly (a portion of which is shown in FIGS. 25A-26) coupled to the outer frame assembly. The inner valve assembly includes an inner frame 450 (a portion of which is shown in FIGS. 25A-26). Some details regarding the valve 400 are not described below. It should be understood that for features and functions not specifically discussed, those features and functions can be the same as or similar to the valve 100 or the valve 200. For example, the valve 400 can also include leaflets (not shown) such as leaflets 270 described above.

FIG. 25A shows a portion of an inner frame 450 of the valve 400 in an expanded configuration and FIG. 26 is an opened and flattened view of the inner frame 450 in an unexpanded configuration. As discussed above for valves 100 and 200, the inner frame 450 of valve 400 can be formed with a shape-memory material and have a biased expanded configuration. For example, the inner frame of the valve 400 can be formed from a laser-cut tube of Nitinol®. Further, the inner frame 450 can be divided into four portions, corresponding to functionally different portions of the inner frame 450 in final form: atrial portion, body portion, strut portion, and tether clamp or connecting portion. A portion of the body portion 442, the strut portion 443, and the tether clamp or connecting portion 444 are shown in FIG. 25A.

In this embodiment, the strut portion 443 can include, for example, six struts 453, such as struts 453A and 453B shown in FIGS. 25A and 25B. As described above for valve 100, the struts 453 can extend to form the tether connecting portion 444, as described in more detail below. The strut portion 443 can also include openings through which connecting members (such as suture filaments and/or wires) can be passed to couple the struts 453 (and the inner frame) to other structures (e.g., to the outer frame assembly), as described previously for valves 100 and 200 above. While FIGS. 25A-26 show the strut portion 443 to include six struts 453 (three pairs of struts 453A and 453B), other embodiments may include fewer or more struts 453.

In this embodiment, two struts 453 (i.e., a strut 453A and a strut 453B) of the six struts 453 can come together to form struts 448 of the tether connecting portion 444. Said another way, a first strut portion 453A and a second strut portion 453B can come together to form a third strut portion 448. For example, as shown in FIG. 25B, two struts 453A and 453B come together to form a strut 448A. Thus, with six struts 453 of the strut portion 443 there are three struts 448 of the tether connecting portion 444. The struts 448 of the tether connecting portion 444 can define openings 451 (see, e.g., FIGS. 25A and 25B) that can be used to secure a tether 436 (shown in FIG. 26) to the inner frame 450 with a suture(s) as described in more detail below.

The combination of two or more struts (e.g., 453A and 453B) to form a tether connecting strut 448 can result in increased wall thickness of the tether connecting struts 448. For example, a wall thickness or width “w” of the portion of the struts 448 alongside the openings 451 (as shown in FIG. 25B) can be increased (when compared to, for example, the wall thickness around the openings in connecting portion 244 of valve 200 in FIG. 6), which can lead to increased tensile capacity of the combined tether connecting portion 444 if the profile/diameter of the connecting portion 444 remains substantially the same as in the valve 200. This increased tensile capacity can provide increased structural integrity of the tether connecting portion 444 and the inner frame 450. In some embodiments, the tensile capacity can be maintained (when compared to the valve 200), while at the same time reducing the profile/diameter of the connecting portion 444 (relative to the valve 200). For example, as shown in FIG. 26, the inner frame 450 does not include “micro-Vs” as described for inner frame 250, which can allow for a reduced profile, or alternatively, the ability to increase the width “w” and increase tensile strength while maintaining the same profile.

As described above for valve 100, the two (or more) struts (e.g. 453A and 453B, shown in FIGS. 25A and 25B) combining to form a single tether connecting strut 448, can be combined and formed integrally or be fused in a preformed manner (as shown in FIGS. 25A and 25B) or can be formed as separate components and coupled together to form a single strut 448 of the tether connecting portion 444.

FIGS. 27-29 illustrate the inner frame 450 of the prosthetic valve 400 coupled at the tether connecting portion 444 to one end of the tether 436 with one or more suture strands 435 (also referred to as “sutures”) to compressively clamp or grip over the end of the tether 436, thereby attaching the tether 436 to the inner frame 450 and the valve 400. For example, the sutures 435 are threaded through openings 451 defined in the connecting portion 444 and wrapped around portions of the tether connecting portion 444 and a portion of the tether 436 disposed within the interior region 456 (see, e.g., FIG. 25A) defined collectively by the struts 453/448 of the connecting portion 444.

In some embodiments, the strut portion of the inner frame of a prosthetic valve can include a positive engagement feature to aid with positioning of the prosthetic heart valve. More specifically, as described above the prosthetic valve can include an engagement feature configured to matingly engage an engagement feature of a positioning device, such as positioning device 190 described above. Another embodiment of an inner frame 550 of a heart valve 500 is shown in FIGS. 30-33. FIG. 30 illustrates a portion of the inner frame 550 in an expanded configuration and coupled to an end of a tether 536, and FIG. 31 is an opened and flattened view of the inner frame 550 in an unexpanded configuration. The prosthetic heart valve 500 can be constructed the same as or similar to, and function the same as or similar to, for example, valves 100, 200, and/or 400 described above. For example, the valve 500 can include an outer frame assembly (not shown) and an inner valve assembly coupled to the outer frame assembly. The inner valve assembly of the valve 500 can include the inner frame 550 which includes an atrial portion (not shown), a body portion 542, a strut portion 543 and a tether clamp or connecting portion 544, as described above for valves 100, 200 and 400, and inner frames 150, 250 and 450.

As shown in FIGS. 30-33, the inner frame 550 of the valve 500 is coupled to the tether 536 with sutures 535 at the tether connecting portion 544. As described above, a pair of struts 553 of the strut portion 543 can combine together or converge into a single strut 548 of the tether connecting portion 544 that can be used to compressively clamp around the tether 536 to couple the tether 536 to the inner frame 550. In this embodiment, the inner frame 550 includes an engagement feature 522 provided by a strut 548 of the tether connecting portion 544, which can matingly engage a corresponding engagement portion of a positioning device (not shown) (e.g., positioning device 190). More specifically, one of the struts 548 is longer (e.g., extends further proximally when implanted within a heart) than the remaining struts 548. The engagement feature 522 can be used to engage with a corresponding opening in a positioning device (not shown), which can be used to radially position the inner frame 550 (and the valve 500).

The positioning device, as described above, can define a lumen through which the tether 536 can be received therethrough, and the positioning device can be inserted through the apex of the heart and moved distally to engage with the valve 500 via the engagement feature 522. For example, during deployment of the valve 500 and when the valve 500 is disposed at least partially within, for example, the atrium of the heart, the positioning device can be inserted through the apex of the heart and a distal end portion of the positioning device can engage with the connecting portion 544 of the valve 500. Upon engagement, the transapical positioning device can be used to radially position the valve 500 within the heart by applying torque to turn or rotate the valve 500 about a longitudinal axis of the tether 536.

While FIGS. 30-33 illustrate an embodiment in which one strut 548 of the tether connecting portion 544 is longer and provides the engagement feature 522, in other embodiments, more than one strut 548 can provide or form the engagement feature 522. Further, although FIGS. 30-33 show the engagement feature 522 to be formed by providing a longer strut 548, in other embodiments an inner frame can include an engagement feature in which one or more struts are reduced in length at the tether connecting portion 544 such that they form a slot or an aperture. Such an aperture could be coupled with a positioning device that has a counter engagement feature in the form of an elongated structure or protrusion to mate with the aperture.

While various embodiments have been described above, it should be understood that they have been presented by way of example only, and not limitation. Where methods described above indicate certain events occurring in certain order, the ordering of certain events may be modified. Additionally, certain of the events may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above

Where schematics and/or embodiments described above indicate certain components arranged in certain orientations or positions, the arrangement of components may be modified. While the embodiments have been particularly shown and described, it will be understood that various changes in form and details may be made. Any portion of the apparatus and/or methods described herein may be combined in any combination, except mutually exclusive combinations. The embodiments described herein can include various combinations and/or sub-combinations of the functions, components, and/or features of the different embodiments described.

In addition, the systems and methods described herein can also be adapted for use with a prosthetic tricuspid valve. For example, in such a case, a procedural catheter can be inserted into the right ventricle of the heart, and the delivery sheath delivered to the right atrium of the heart either directly (transatrial), or via the jugular or femoral vein. 

1. A prosthetic heart valve, comprising: an outer frame; an inner frame coupled to the outer frame, the inner frame including a tether coupling portion disposed at a proximal end portion of the prosthetic heart valve; and an anchoring tether coupled to the tether coupling portion of the inner frame with at least one suture, the anchoring tether configured to be secured to a wall of a heart a patient to secure a position of the prosthetic heart valve within the heart of the patient.
 2. The prosthetic heart valve of claim 1, wherein the tether coupling portion defines an interior region, a distal end portion of the anchoring tether disposed within the interior region.
 3. The prosthetic heart valve of claim 1, wherein the tether coupling portion of the inner frame includes a plurality of struts, each strut from the plurality of struts defining at least one opening, the at least one suture being received through the at least one opening and wrapped around at least a portion of the tether coupling portion and a portion of the anchoring tether to secure the anchoring tether to the tether connecting portion.
 4. The prosthetic heart valve of claim 3 wherein each of the plurality of struts includes a first portion, a second portion and a third portion, the first portion and the second portion converging into the third portion, the third portion defining the at least one opening.
 5. The prosthetic heart valve of claim 3, wherein the plurality of struts collectively define an interior region, a distal end portion of the anchoring tether disposed within the interior region.
 6. The prosthetic heart valve of claim 1, wherein the tether coupling portion includes a first engagement feature configured to matingly and releasably engage a second engagement feature of a positioning device, the positioning device configured to help position the prosthetic heart valve in the heart of the patient.
 7. The prosthetic heart valve of claim 6, wherein the tether coupling portion of the inner frame includes a plurality of struts, the first engagement feature includes a first strut from the plurality of struts being longer than the remaining struts from the plurality of struts, the first strut configured to be matingly received within an opening defined by the positioning device to releasably couple the inner frame to the positioning device.
 8. The prosthetic heart valve of claim 1, wherein the anchoring tether is formed with a flexible braid.
 9. The prosthetic heart valve of claim 4, wherein the first portion, the second portion and the third portion of the plurality of struts are formed integrally.
 10. A kit, comprising: a prosthetic heart valve including an outer frame, an inner frame coupled to the outer frame, and an anchoring tether coupled to the inner frame, the inner frame including a tether coupling portion disposed at a proximal end portion of the prosthetic heart valve, the anchoring tether coupled to the tether coupling portion of the inner frame with at least one suture, the anchoring tether configured to be secured to a wall of a heart of a patient to secure a position of the prosthetic heart valve within the heart of the patient; and a positioning device configured to engage the tether coupling portion of the inner frame and used to help position the prosthetic heart valve within the heart of the patient.
 11. The kit of claim 10, wherein the tether coupling portion includes a first engagement feature configured to be matingly coupled to a second engagement feature of positioning device.
 12. The kit of claim 11, wherein the tether coupling portion of the inner frame includes a plurality of struts, the first engagement feature includes a first strut from the plurality of struts being longer than the remaining struts from the plurality of struts, the first strut configured to be matingly received within a slot defined by the positioning device to releasably couple the inner frame to the positioning device.
 13. The kit of claim 10, wherein the tether coupling portion defines an interior region, a distal end portion of the anchoring tether disposed within the interior region.
 14. The kit of claim 10, wherein the tether coupling portion of the inner frame includes a plurality of struts, each strut from the plurality of struts defining at least one opening, the at least one suture being received through the at least one opening and wrapped around at least a portion of the tether coupling portion and a portion of the anchoring tether to secure the anchoring tether to the tether connecting portion.
 15. The kit of claim 14, wherein each of the plurality of struts includes a first portion, a second portion and a third portion, the first portion and the second portion converging into the third portion, the third portion defining the at least one opening.
 16. The kit of claim 14, wherein the plurality of struts collectively define an interior region, a distal end portion of the anchoring tether disposed within the interior region.
 17. The kit of claim 10, wherein the anchoring tether is formed with a flexible braid.
 18. The kit of claim 15, wherein the first portion, the second portion and the third portion of the plurality of struts are formed integrally. 